NCT00707954已完成1 期
A Clinical Pharmacology Study of Multiple Doses of TA-7284 in Patients With Type 2 Diabetes Mellitus
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 61
- 试验地点
- 1
- 主要终点
- Safety: Adverse Events, Adverse Drug Reactions
研究概览
简要总结
The purpose of this study is to evaluate the safety, pharmacokinetics and pharmacodynamics of TA-7284 orally administered once daily for 15 days (1 day followed by a 1 day washout period and then 14 consecutive days). Dose escalation design is utilized in this study, and dose escalation of TA-7284 will be starting with 25 mg (step 1). Subsequent doses of 100 mg (step 2), 200 mg (step 3) and 400 mg (step 4) are planned after review of the tolerance and PK of the previous step.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinically stable Type 2 Diabetes Mellitus
- •Females without childbearing potential
- •Body mass index (BMI) >= 18.5 kg/m2 and <= 39.9 kg/m2
- •Hemoglobin A1c levels >= 6.5% and <= 10%
- •Fasting blood glucose levels >= 140 mg/dL and <= 270 mg/dL
- •Systolic blood pressure >= 95 mmHg and <= 160 mmHg, and diastolic blood pressure >= 50 mmHg and <= 100 mmHg, and pulse rate >= 50 bpm
- •Patients who have not been administered anti-diabetic medication within 2 weeks Prior to dosing
- •Medicines if necessary for Hypertension or Dyslipidemia should be administered with stable dosage at least 3 months
- •Treatment with diet and exercise should be unchanged for more than 3 months
排除标准
- •Type 1 Diabetes Mellitus or Secondary Diabetic Mellitus
- •History of diabetic complications which need treatment
- •Treatment with insulin, thiazolidinediones, thiazide diuretics、beta blockers or systemic steroids within 3 months prior to informed consent
- •Serum creatinine > upper limit of the normal range
- •Patients with significant complications
研究组 & 干预措施
TA-7284
Experimental
干预措施: TA-7284 (Drug)
Placebo of TA-7284
Placebo Comparator
干预措施: Placebo of TA-7284 (Drug)
结局指标
主要结局
Safety: Adverse Events, Adverse Drug Reactions
时间窗: 19 days
In the safety analysis population, adverse events incidences and adverse drug reactions incidences were calculated by dose.
次要结局
- Pharmacokinetics- 1)Plasma Concentration of TA-7284: Tmax,Cmax, AUC, Etc.; and 2)Urinary Excretion of TA-7284: Ae, Ae%, CLr(19 days)
- Pharmacodynamics- 1)Urinary Glucose Excretion; 2)Plasma Glucose Concentration; 3)Insulin Concentration in Serum; 4)Insulinogenic Index;and 5)Hemoglobin A1c and Glycoalbumin(18 days)
研究者
研究点 (1)
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